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Experience with clinical and regulated non-clinical auditStrong acumen and demonstrated ability in GLP/GCP auditing , FDA and EMEA regulations inclusive of direct experience with Pharmacovigilance and System Development Life Cycle activities.
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Interact routinely and will develop a strong team environment with colleagues throughout GRSRequirements:Ph. D., M.D., PharmD. , MS or commensurate experienceSignificant experience in regulatory affairs (e.g. 3-5 years)Expert understanding of policy, laws, regulations and guidelines as they apply to U.S. FDA for drug development and approval.
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Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
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Demonstrates knowledge of industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines. BS/BA degree in Statistics, Mathematics, or Computer Science or in a related field and 2+ years of Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer programming CDISC data structures\ OR.
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G: US FDA, EU MDR, TGA, MHLW, NMPA, etc. Develop and maintain an effective working relationship with US FDA and other international regulatory bodies/competent authorities. You have Relevant training, experience and/or certifications (ASQ Quality Manager, Auditor, Six Sigma, DFSS, reliability engineering), Continuous Improvement methodologies and Quality tools such as Lean, Six Sigma, 5 Why’s, Fishbone, etc.
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Performs assays in a high throughput laboratory, as well as performing specimen processing duties in accordance with laboratory SOPs, manufacturer guidelines and CAP/ FDA regulations. ASCP certifications for cytology, histology, microbiology, serology-immunology, hematology, clinical chemistry, and/or immunohematology preferred.
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Act as a resource for the research studies' regulatory activities including, but not limited to, interpreting, preparation, coordination, implementation and compliance with the Institutional Review Board (IRB) guidelines, FDA requirements, and Good Clinical Practice procedures.
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In executing these position responsibilities, the Clinical Research Coordinator is guided by FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.
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Pharmaceutical industrial engineering knowledge (pharmaceutical design, development, manufacturing, and regulatory requirements) to optimize technical transfer from lab-scale to kilo lab/pilot plant production; Implement hazard operability analysis and risk assessment skills to draft batch records and safety reports; Analyze lab and production data using NMR instrumentation, data interpretation, Chromatography to ensure FDA regulatory compliance and maintain quality standards.
$93,000 - $120,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Clear understanding of the drug development process, submission-related activities and regulatory requirements (eg, CDISC, CDASH, eCTD) and guidelines (eg, ICH, CHMP, FDA, GCP). Arcturus’ commitment to the development of novel RNA therapeutics has led to collaborations including, amongst others, Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Ultragenyx Pharmaceutical, Inc., and the Cystic Fibrosis Foundation.
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This role is expected to act as a thought partner, working with other leadership members to assure that operations in all departments run smoothly and maintain compliance with relevant regulations, including those originating from the FDA, the USDA, the NIH, or other regulatory bodies.
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We are hiring for a QA Director to join a nonclinical CRO working with both small and large animal models while working collaboratively with groups that span biotechnology research. Terminal degree (DVM, PhD, MD) in pharmaceutical, biological, or chemical sciences.
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5-10 years of experience in FDA regulatory law, preferably with a focus on counseling companies with FDregulated products. Provide legal advice and guidance to clients on FDA regulatory requirements for products regulated by the FDA.
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Manage and/or support global clinical trials (Phase 1-3) in oncology indications, ensuring that studies are carried out in accordance with the clinical development plan, ICH-GCP, and FDA/other regulatory agency requirements.
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Assist with initiation, implementation and management of research projects in accordance with GCP, FDA, HIPAA & all required regulatory guidelines, with an emphasis on pediatric clinical research studies.
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fda job in San Diego, CA
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